ALICE 6, LDXS HEADBOX
Received Apr 23, 2024 · Event occurred Apr 14, 2024
Report 2518422-2024-21857 · MDR key 19169162
Device
Generic name
Standard Polysomnograph With Electroencephalograph
Manufacturer
Respironics, Inc.Model number
1063552Catalog number
1063552
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A CUSTOMER WAS PLUGGING IN AN ALICE 6 HEAD BOX, THEY RECEIVED A SHOCK. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
THE MANUFACTURER PREVIOUSLY REPORTED THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A CUSTOMER WAS PLUGGING IN AN ALICE 6 HEAD BOX, THEY RECEIVED A SHOCK. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE DEVICE EVALUATION, THE DEVICE MAIN BOARD WAS FOUND TO BE DAMAGED. ADDITIONALLY, THE DEVICE'S FRONT COVER WAS FOUND TO BE DAMAGED. THE MAIN BOARD WAS REPLACED, THE TOP ENCLOSURE ASSEMBLY WAS REPLACED AND THE DEVICE WAS CLEANED.